MICOR 700 with Auto I/A

• K Number: K243395
• Device Name: MICOR 700 with Auto I/A
• Manufacturer: Carl Zeiss Meditec Cataract Technology Inc.
• Date Cleared: 2025-08-08 ( 281 days)
• Product Code: HQC
• Regulation Number: 886.4670
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The intended use of the MICOR 700 System with Auto I/A is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the MICOR 700 with Auto I/A does not contain information regarding the acceptance criteria or the study that proves the device meets those criteria. The letter primarily focuses on the regulatory aspects of the clearance, such as the substantial equivalence determination, applicable regulations, and administrative requirements.

To answer your request, I would need access to a different document, such as the 510(k) summary or the full submission, which typically contains details about performance testing, validation studies, and the established acceptance criteria.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.